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Key Documents

K030A05HH1

Millipore

Opticap® XL5 Clarigard®

inlet connection diam. 9/16 in., pore size 3.0 μm, cartridge nominal length 5 in. (12.5 cm)

Sinonimo/i:

Opticap XL5 Clarigard 3.0 μm 9/16 in. HB/HB

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About This Item

Codice UNSPSC:
23151806
eCl@ss:
32031690

Materiali

polypropylene
polypropylene housing
polypropylene support
polypropylene vent cap
silicone seal

Livello qualitativo

Conformità normativa

meets FDA Indirect Food Additive requirements cited in 21 CFR 177-182 (all component materials)

Produttore/marchio commerciale

Opticap®

Parametri

1.0 bar max. inlet pressure (15 psi) at 80 °C
2.75 bar max. inlet pressure (40 psi) at 60 °C
25 °C max. inlet temp.
4.8 bar max. differential pressure (70 psid) at 20 °C
5.5 bar max. inlet pressure (80 psi) at 23 °C
80 psig max. inlet pressure

Lunghezza

21.6 cm (8.5 in.)

Lunghezza nominale della cartuccia

5 in. (12.5 cm)

Diametro

10.7 cm (4.2 in.)

Diam. connessione ingresso

9/16 in.

Amp. ingresso/ uscita

21.6 cm (8.5 in.)

Diam. connessione uscita

9/16 in.

Impurezze

≤0.25 EU/mL bacterial endotoxins (LAL test, Aqueous extraction)
<0.25 EU/mL USP bacterial endotoxins (LAL test, sample aqueous extraction)

Estraibili (gravimetria)

≤10 mg/capsule

Matrice

Clarigard®

Dimensione pori

3.0 μm nominal pore size
3.0 μm pore size

input

sample type liquid

Raccordi

inlet hose barb
14 mm (9/16 in.) inlet/outlet hose barb
outlet hose barb

Descrizione generale

Device Configuration: Capsule

Confezionamento

Double Easy-Open bag

Altre note

These products are manufactured in a facility which adheres to FDA Good Manufacturing Practices.
Directions for Use

  • Organism Retention: Microorganism
  • Mode of Action: Filtration (size exclusion)
  • Application: BioProcessing
  • Intended Use: Reduction or removal of microorganism/bioburden
  • Instructions for Use: Please refer installation section of OPTICAP® XL Capsules and OPTICAP® XLT Capsules user guide
  • Storage Statement: Store in dry location.
  • Disposal Statement: Dispose of in accordance with applicable federal, state and local regulations.

Nota sulla preparazione

Sterilization Method
3 autoclave cycles of 30 min @ 126 °C; not in-line steam sterilizable
This product was manufactured with a media combination which meets the criteria for a "non-fiber releasing" filter as defined in 21 CFR 210.3 (b) (6).

Risultati analitici

Gravimetric Extractables: after 24 hours in water at controlled room temperature
Will meet the USP Oxidizable Substances Test requirements after a water flush of ≥2 L

Note legali

CLARIGARD is a registered trademark of Merck KGaA, Darmstadt, Germany
OPTICAP is a registered trademark of Merck KGaA, Darmstadt, Germany

Esclusione di responsabilità

EMD Millipore Corporation certifies that this product complies with the European Pressure Equipment Directive, 97/23/EC of 29 May 1997. This product has been classified under Article 3 § 3 of the Pressure Vessel Directive. It has been designed and manufactured in accordance with sound engineering practice to ensure safe use. In compliance with Article 3 § 3 of this Pressure Vessel Directive, this product does not bear the CE mark.

Certificati d'analisi (COA)

Cerca il Certificati d'analisi (COA) digitando il numero di lotto/batch corrispondente. I numeri di lotto o di batch sono stampati sull'etichetta dei prodotti dopo la parola ‘Lotto’ o ‘Batch’.

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